BlackBio Gets CE Mark Approval for BlackLight Fungal ID Kit, Designed to Specifically Identify Fungal Species

Blackbio, dedicated to developing and marketing new solutions for personalized medicine, has obtained CE Marking for BlackLight Fungal ID Kit, intended for a fast and easy‐to‐use diagnostic test, allowing rapid identification of fungal infections.

BlackLight Fungal ID Kit allows the detection and identification of the most clinically relevant fungi and yeast species by microsequencing (Candida and Aspergillus), responsible for about 95% of all invasive fungal diseases characterized by a high mortality rate (30-40%).

BlackLight Fungal ID Kit minimizes handling, being faster than traditional methods currently on the market for routine diagnostics in hospitals and intensive care units.

Complete process takes less than 4 hours, allowing prescription of an adequate antifungal treatment in a short time, avoiding resistances and improving survival. In comparison, current use of media culture in combination with serological or biochemical tests usually take from a few days to one month for the identification of these pathogens.

In recent years there has been an exponential increase in the incidence of serious fungal infections associated mainly with Candida and Aspergillus, with high morbidity and mortality. These are often associated with surgery, organ transplants, tumours and intensive care patients, and the epidemiology of these infections is changing in parallel with advances in clinical practice, transforming the risk population.

All this justifies the need for a fast and easy to use kit for the diagnostic of fungi and yeast in order to improve prognosis and treatment.